Efficacy, Immunogenicity, and Safety of the Two-Dose Schedules of TURKOVAC versus CoronaVac in Healthy Subjects: A Randomized, Observer-Blinded, Non-Inferiority Phase III Trial
Mine Durusu Tanriover,
Ozlem Altuntas Aydin,
Rahmet Guner,
Orhan Yildiz,
Ilhami Celik,
Hamdi Levent Doganay,
Sukran Kose,
Sila Akhan,
Emin Halis Akalin,
Zafer Sezer,
Aykut Ozdarendeli,
Serhat Unal,
on behalf of the TURKOVAC Study Group
Affiliations
Mine Durusu Tanriover
Department of Internal Medicine, Hacettepe University Faculty of Medicine, 06230 Ankara, Türkiye
Ozlem Altuntas Aydin
Department of Infectious Diseases and Clinical Microbiology, University of Health Sciences, Başaksehir Cam and Sakura City Hospital, 34480 Istanbul, Türkiye
Rahmet Guner
Infectious Diseases and Clinical Microbiology Clinic, Ankara Yildirim Beyazit University, Ankara City Hospital, 06800 Ankara, Türkiye
Orhan Yildiz
Department of Infectious Diseases and Clinical Microbiology, Erciyes University Faculty of Medicine, 38030 Kayseri, Türkiye
Ilhami Celik
Department of Infectious Diseases and Clinical Microbiology, Kayseri City Training and Research Hospital, 38080 Kayseri, Türkiye
Hamdi Levent Doganay
Department of Gastroenterology, Medical Park Pendik Hospital, 34899 Istanbul, Türkiye
Sukran Kose
Infectious Diseases Clinic, University of Health Sciences, Izmir Tepecik Training and Research Hospital, 35020 Izmir, Türkiye
Sila Akhan
Department of Infectious Diseases and Clinical Microbiology, Kocaeli University Faculty of Medicine, 41001 Kocaeli, Türkiye
Emin Halis Akalin
Department of Infectious Diseases and Clinical Microbiology, Bursa Uludag University Faculty of Medicine, 16059 Bursa, Türkiye
Zafer Sezer
Department of Medical Pharmacology, Erciyes University Faculty of Medicine, 38030 Kayseri, Türkiye
Aykut Ozdarendeli
Department of Microbiology, Erciyes University Faculty of Medicine, 38030 Kayseri, Türkiye
Serhat Unal
Vaccine Institute, Hacettepe University, 06230 Ankara, Türkiye
We present the interim results of the efficacy, immunogenicity, and safety of the two-dose schedules of TURKOVAC versus CoronaVac. This was a randomized, observer-blinded, non-inferiority trial (NCT04942405). Volunteers were 18–55 years old and randomized at a 1:1 ratio to receive either TURKOVAC or CoronaVac at Day 0 and Day 28, both of which are 3 μg/0.5 mL of inactivated severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) adsorbed to aluminum hydroxide. The primary efficacy outcome was the prevention of polymerase chain reaction (PCR)-confirmed symptomatic coronavirus disease 2019 (COVID-19) at least 14 days after the second dose in the modified per-protocol (mPP) group. Safety analyses were performed in the modified intention-to-treat (mITT) group. Between 22 June 2021 and 7 January 2022, 1290 participants were randomized. The mITT group consisted of 915 participants, and the mPP group consisted of 732 participants. During a median follow-up of 90 (IQR 86–90) days, the relative risk reduction with TURKOVAC compared to CoronaVac was 41.03% (95% CI 12.95–60.06) for preventing PCR-confirmed symptomatic COVID-19. The incidences of adverse events (AEs) overall were 58.8% in TURKOVAC and 49.7% in CoronaVac arms (p = 0.006), with no fatalities or grade four AEs. TURKOVAC was non-inferior to CoronaVac in terms of efficacy and demonstrated a good safety and tolerability profile.
